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ISRCTN
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ISRCTN38366450
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ClinicalTrials.gov identifier
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Public title
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A multicentre, randomised, double-blind, placebo-controlled trial to evaluate intravenous infusion of salbutamol versus saline for 28-day mortality in patients with acute respiratory distress syndrome
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Scientific title
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Acronym
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BALTI-2
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Serial number at source
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Version 2
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Study hypothesis
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In patients with acute respiratory distress syndrome (ARDS), treatment with intravenous salbutamol will reduce 28-day mortality
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Lay summary
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Not provided at time of registration
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Ethics approval
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West Midlands Multicentre Research Ethics Committee, approval pending as of 01/05/2006
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Study design
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Randomised, double-blind, placebo-controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Acute respiratory distress syndrome
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Participants - inclusion criteria
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On day 1 following intensive care unit (ICU) admission, the primary caring ICU clinician should consider all adult patients (age ≥18 years) with severe hypoxaemic respiratory failure (PaO2/FiO2) ≤26.7 kPa to be eligible for inclusion in the trial
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Participants - exclusion criteria
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1. Pregnancy
2. Cardiogenic pulmonary oedema (confirmed by medical history and chest x-ray)
3. Severe obstructive airway disease requiring nebulised or intravenous (IV) beta 2-agonists
4. Treatment with beta 2-blockers ≤48 hours
5. Brain stem death
6. Treatment withdrawal ≤24 hours, which indicates any interventions (including a trial) would be considered inappropriate
7. Refusing consent or patients in whom relatives refuse assent
8. Enrolled in another interventional clinical trial in the last 28 days
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Anticipated start date
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01/08/2006
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Anticipated end date
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01/09/2007
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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100
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Interventions
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Salbutamol or placebo will be administered through a dedicated intravenous line for seven days
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Primary outcome measure(s)
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Mortality 28 days after randomisation
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Secondary outcome measure(s)
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1. Number of ventilator-free days
2. Mortality at (first) discharge from ICU
3. Mortality at discharge from hospital
4. Mortality at 12 months post randomisation
5. ICU length of stay
6. Hospital length of stay
7. Disability and quality of life at 12 months after randomisation
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Sources of funding
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Intensive Care Society
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Trial website
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Publications
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2011 protocol in http://www.ncbi.nlm.nih.gov/pubmed/21554679
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Contact name
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Prof
Fang
Gao
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Address
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Adult Intensive Care Unit
Birmingham Heartlands Hospital
Bordesley Green East
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City/town
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Birmingham
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Zip/Postcode
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B9 5SS
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Country
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United Kingdom
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Sponsor
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Heart of England NHS Foundation Trust (UK)
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Address
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Birmingham Heartlands Hospital
Bordesley Green East
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City/town
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Birmingham
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Zip/Postcode
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B9 5SS
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Country
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United Kingdom
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Date applied
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14/04/2006
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Last edited
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21/09/2011
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Date ISRCTN assigned
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07/07/2006
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